Efficacy, safety, and tolerability of antihypertensive therapy with aliskiren/amlodipine in clinical practice in Austria. The RALLY (Rasilamlo long lasting efficacy) study
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This observational study evaluated the efficacy and tolerability of 3-month aliskiren/amlodipine therapy under outpatient conditions.
This Austria-wide observational study included 579 hypertensive patients (566 [98 %] who could be analyzed biometrically) under the care of 140 physicians. The average age of the patient collective was 64 ± 11 years and the mean duration of hypertension was 10 ± 7 years. Regarding 92 % of the study participants, an antihypertensive therapy already existed. Efficacy was assessed in accordance with the Austrian hypertension guidelines while tolerability was evaluated on the basis of adverse events. A descriptive physician judgment based on efficacy, tolerability, and compliance was available for 539 patients (95 %). Office blood pressure values were used for the evaluation.
On average, the systolic and diastolic blood pressures were reduced from 161 ± 14 to 135 ± 10 mmHg and 93 ± 9 to 81 ± 6 mmHg, respectively. Blood pressure values of < 140/90 mmHg and < 130/80 mmHg were achieved in 56 and 7 % patients, respectively. A subgroup analysis of 242 patients (43 %) with diabetes mellitus and/or renal disease, as well as those with a high cardiovascular risk, demonstrated nearly identical results compared to the total population. Overall, 44 adverse events were documented in 41 patients, and physicians reported that 94 % of patients were compliant in a final survey on evaluation of therapy.
The fixed-dose combination of aliskiren/amlodipine provided clinically relevant blood pressure reductions along with good tolerance and compliance. During the 3-month duration of observation under outpatient conditions, it was seen that aliskiren and amlodipine reduced the systolic and diastolic blood pressures on average by 26 and 13 mmHg, respectively.
KeywordsHypertension Observational study Aliskiren/amlodipine Fixed-dose combination therapy Renin–angiotensin–aldosterone system (RAAS)
The authors thank all patients who were willing to share their medical data. In particular, they would like to thank all participating physicians who documented these data and thereby enabled the observational study.
Conflict of interest
A.R. Rosenkranz received speakers fee from Novartis, M. Ratzinger was an employee of Novartis.
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